Patients with Prostate Cancer of Clinical Stage T1c-T3N0M0
Conditions
Interventions
Carbon-ion radiation therapy A total of 51.6Gy(RBE) consisting of 12 fractions
once a day 4.3 Gy(RBE), 6-8 times for 2 weeks
Sponsors
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed primary prostate adenocarcinoma 2) Either clinical stage of T1c, T2a, T2b, T2c, T3a, or T3b and N0M0, in accordance with UICC 7th (2009) 3) ECOG Performance status is 0, 1 or 2 4) Twenty years old of age at registration or more 5) Untreated patient for prostate cancer, except for those who undergo neoadjuvant endocrine therapy 6) Patients are informed for diagnosis of prostate cancer and independently agree with this study on carbon-ion radiotherapy
Exclusion criteria
Exclusion criteria: 1) Patient with past history of radiotherapy for the targeted lesion 2) Patient with castration-resistant prostate cancer 3) Patient with active double cancer 4) Patient with active and intractable infection in the targeted lesion. 5) Patient with metal devices in the lesion which will cause adverse risk by carbon-ion radiotherapy 6) Patient eligible for Advanced Medicine Program B (Sen-shin Iryo B) 7) Other medical or psychological condition which is unsuitable for carbon-ion therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemical progression-free survival at 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall survival 2) Disease-specific survival 3) Event-free survival 4) Early and late-phase adverse event rate | — |
Countries
Japan
Contacts
Public ContactHiroyuki Katoh
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization Center for Carbon-ion Radiotherapy
Outcome results
None listed